1. Field of the Invention
This invention relates generally to formulations incorporating human chorionic gonadotropin for administration to mammals to facilitate weight loss and body contouring.
2. Description of the Related Art
hCG (human chorionic gonadotrophin) is a hormone that is naturally produced during pregnancy. hCG is a glycoprotein hormone normally secreted by trophoblastic cells of the placenta during pregnancy. It consists of two chains, called the alpha and beta subunits. It is believed that one of the functions of hCG in pregnancy is to provide a constant supply of fat to the fetus regardless of what or when the mother eats. And, in particular, hCG works to supply both mother and fetus with a steady source of nutrition and fuel in the event of some kind of starvation state. For example, if the mother is ill and cannot keep food down, then hCG will break down stored fat and the baby will be born weighing approximately a normal weight (i.e. 6 or 7 lbs).
It has been postulated that there are two types of fat in the body: structural fat and excess fat. Structural fat is used by the body to provide support and fuel to vital organs. Excess fat is fat that goes directly into storage in the body. It has been found that hCG administered through injections in very small amounts in combination with a modified diet has the capability of targeting excess fat storage for use in providing support to the vital organs. Thus, hCG injections together with a modified diet result in weight loss in the areas where there is the most excess fat storage.
The beneficial effects of hCG administered by injection have been known in the medical and weight-loss industries for many years. Studies have shown that administering hCG by daily injection in small doses, e.g., 125 I.U., facilitates weight loss and redistribution of fat in human patients. See The Action of Chorionic Gonadotrophin in the Obese, A. T. W. Simeons (The Lancet, Nov. 6, 1954). Daily hCG injections administered over a period of ten days without concomitantly subjecting patients to a modified diet result in lower measurements around the hips and waists of the patients but no significant weight loss. These injections also lead to partial appetite suppression and eliminate sudden compulsive hunger experienced by some patients soon after consuming heavy meals. When combined with a modified diet, such as a very low calorie diet, the hCG injections result in significant weight loss in addition to “body contouring” (loss of excess fat in storage areas). Studies also show that this regime of hCG injections coupled with a 500 calorie/day diet does not lead to vitamin or protein deficiencies. Multiple other benefits have been observed in association with this regime. Patients that are overweight due to diabetes lose weight in response to the regime without developing acetonemia, and in cases of mild diabetes patients maintain normal blood sugar levels while weight loss is maintained; weight gain following this regime accompanied by higher sugar levels can be counteracted by another course of the regime. Following this regime, patients with gout have reduced or normal blood-uric acid levels; these patients remain well following treatment while they maintain their weight loss. Similarly, abnormally high blood-cholesterol levels decrease in patients following the regime with free cholesterol increasing and the esterified fraction decreasing, mirroring values seen in pregnancy. Treatment according to this regime also increases libido and decreases or eliminates oligomenorrhea, hyperestrogenic dysmenorrhea, fluor albus simplex, abnormal hair loss, peptic ulcer symptoms, and various dermatoses. Following the regime has also been found to cause brittle finger-nails and improve the quality of singers' voices.
However, administration of hCG by injection has created many problems for both patients and practitioners.
For patients, the process is painful and inconvenient. The injection must be given daily so patients either have to visit a clinic every day or be trained to inject themselves. Even for trained patients administering the injections can be inconvenient because the hCG solution must be refrigerated. Proper disposal of the needles and syringes is also problematic for patients and a major concern for physicians. Another potential difficulty is that in order for the injections to be effective they must be administered subcutaneously in a very specific way.
For medical practitioners, it may be hard to get consistent results depending on whether patients visit clinics daily for the injections or inject themselves properly. Another major concern is that many patients are very needle-phobic and cannot participate in an hCG program that requires the hCG to be administered by injection.
For a long period of time, medical practitioners have dealt with the drawbacks of using hCG injections because it was believed that changing the route of administration of hCG would change its biological activity such that it would not be effective for the treatment of obesity. This belief was challenged in 2003 when Dr. Daniel Belluscio of Buenos Aires, Argentina published a study on the internet suggesting that oral formulations of hCG could also be effective in promoting weight loss. See Utility of an Oral Presentation of hCG for the Management of Obesity: A Double Blind Study, Dr. Daniel Belluscio, Dr. Leonor Ripamonte, and Dr. Marcelo Wolansky (http://drbelluscio.tripod.com/hcg.htm).
There remains an unmet need in the art for oral hCG formulations and methods of administering such formulations for facilitating weight loss and body contouring as effectively as hCG injections.